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India ends Bayer cancer drug monopoly

19th March 2012

India has ruled to allow a local generic drug manufacturer to make the cancer drug sorafenib tosylate, effectively ending the monopoly of German pharmaceutical giant Bayer.

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In a landmark ruling, the Indian Patent Office issued a compulsory licence to the company on the basis that Bayer had failed to price the drug at a level that was affordable to local people.

The ruling comes under the TRIPS intellectual property agreements governed by the World Trade Organisation.

The drug is currently used to treat kidney and liver cancer, and is being made available generically because Bayer was also judged not to be able to make a reliable supply available for Indians to use.

The charity Médecins Sans Frontières (MSF) welcomed the news as a hopeful sign.

Tido von Schoen-Angerer, director of the group's Access Campaign for affordable medicines said the case was important because until now, newer drugs to treat HIV had been patented in India by pharmaceutical companies, putting them out of the reach of Indian HIV/AIDS patients.

He said the latest decision offered hope for the future because it showed that new, patented and expensive drugs could also be manufactured generically for a fraction of the price.

Under the TRIPS agreement, the Indian manufacturer will pay royalties to the patent holder for the drug.

The arrangement is designed to compensate patent-holders for their investment in developing the drug, while ensuring that patients in poorer countries are not denied life-saving medication.

The price of sorafenib tosylate made by the Indian manufacturer will now fall by 97% from US$5,500 per month to around US$175 per month.

MSF's Michelle Childs said the ruling would serve as a warning to big pharma that price-gouging and limiting availability would not be tolerated by the international community.

Childs said the Patent Office could and would end monopoly powers where access to important medicines was at stake.

She called for the precedent to be applied to other drugs and expanded to include exports.

This would have a direct impact on affordability of medicines used by MSF, and boost the accessibility of critically needed drugs, she added.

The TRIPS Agreement governs trade and intellectual property rules, and provides for compulsory licences as a legally recognised means to overcome barriers in accessing affordable medicines.

India is not the first country to make use of compulsory licensing. The US Patent Office approved a generic skin graft device for sale in the United States, ordering the manufacturer to pay royalties to the patent holder in a February 2011 decision.


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